Indications for: TDVAX
Tetanus and diphtheria immunization in patients ≥7yrs.
The efficacy against tetanus of Tdvax is supported by the following:
Response to primary series. Of 20 adults with less than 0.0025 units/mL of tetanus antitoxin in preimmunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of Tdvax (2 Lf tetanus toxoid dose). After 3 doses of Tdvax, 16 of 16 adults achieved 0.01 antitoxin units/mL.
Response to booster doses. Booster doses of Tdvax at doses of 1 Lf and 5 Lf of tetanus toxoid induced tetanus antitoxin levels greater than 0.01 units/mL when administered to all 36 adults who had received prior tetanus immunizations.
The efficacy against diphtheria of Tdvax is supported by the following:
Response to primary series. Of 10 adults with less than 0.001 units/mL of diphtheria antitoxin in preimmunization serum, 50% had antitoxin concentrations of 0.01 or greater after 2 doses of Tdvax (2 Lf diphtheria toxoid dose). After 3 doses of Tdvax, 6 of 6 adults achieved 0.01 antitoxin units/mL.
Response to booster doses. In clinical trials, booster doses of TDVAX formulated to contain 1 Lf and 5 Lf of diphtheria toxoid, both induced antitoxin levels greater than 0.01 units/mL when administered to adults with prior diphtheria immunity. In 140 adolescent males given a single booster dose of the 1 Lf formulation, all achieved an antitoxin titer of 0.01 units/mL or higher.
Adults and Children:
<7yrs: not established. ≥7yrs: Give IM in deltoid muscle. Previously unvaccinated: three 0.5mL doses at elected date, then 4–8 weeks after first dose, and 6–12 months after second dose. Give booster dose at 11–12yrs of age and every 10yrs thereafter. Diphtheria and tetanus prophylaxis: see full labeling.
Anaphylaxis associated with a previous dose.
Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid vaccine. Previous Arthus-type hypersensitivity reaction: not recommended until ≥10yrs after prior dose of tetanus toxoid-containing vaccine. Immunodeficiency. Have epinephrine (1:1000) available. Elderly. Pregnancy: administer only if clearly needed. Nursing mothers.
Concomitant vaccines: no safety and immunogenicity data are available. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Inj site reactions (eg, pain, erythema, tenderness, pruritis), dizziness, headache, myalgia, rash, nausea, arthralgia.
Generic Drug Availability:
Single-dose vials (0.5mL)—10